title: The Cosmetics Europe strategy for animal-free genotoxicity testing: project status up-date.
abstract: The Cosmetics Europe (formerly COLIPA) Genotoxicity Task Force has driven and funded three projects to help address the high rate of misleading positives in in vitro genotoxicity tests: The completed "False Positives" project optimized current mammalian cell assays and showed that the predictive capacity of the in vitro micronucleus assay was improved dramatically by selecting more relevant cells and more sensitive toxicity measures. The on-going "3D skin model" project has been developed and is now validating the use of human reconstructed skin (RS) models in combination with the micronucleus (MN) and Comet assays. These models better reflect the in use conditions of dermally applied products, such as cosmetics. Both assays have demonstrated good inter- and intra-laboratory reproducibility and are entering validation stages. The completed "Metabolism" project investigated enzyme capacities of human skin and RS models. The RS models were shown to have comparable metabolic capacity to native human skin, confirming their usefulness for testing of compounds with dermal exposure. The program has already helped to improve the initial test battery predictivity and the RS projects have provided sound support for their use as a follow-up test in the assessment of the genotoxic hazard of cosmetic ingredients in the absence of in vivo data.
authors.affiliation: Procter & Gamble Co., 1 Procter and Gamble Plz, Cincinnati, OH, USA. Electronic address: pfuhler.s@pg.com.
authors.forename: S
authors.initials: S
authors.lastname: Pfuhler
authors.forename: R
authors.initials: R
authors.lastname: Fautz
authors.forename: G
authors.initials: G
authors.lastname: Ouedraogo
authors.forename: A
authors.initials: A
authors.lastname: Latil
authors.forename: J
authors.initials: J
authors.lastname: Kenny
authors.forename: C
authors.initials: C
authors.lastname: Moore
authors.forename: W
authors.initials: W
authors.lastname: Diembeck
authors.forename: N J
authors.initials: NJ
authors.lastname: Hewitt
authors.forename: K
authors.initials: K
authors.lastname: Reisinger
authors.forename: J
authors.initials: J
authors.lastname: Barroso
mesh_terms: D000279:Administration, Cutaneous; D000826:Animal Testing Alternatives / Q000379:methods; D000818:Animals; D020552:Comet Assay / Q000379:methods; D003358:Cosmetics / Q000008:administration & dosage / Q000633:toxicity*; D005060:Europe; D005189:False Positive Reactions; D006801:Humans; D015162:Micronucleus Tests / Q000379:methods; D008954:Models, Biological; D009152:Mutagenicity Tests / Q000379:methods*; D015203:Reproducibility of Results; D012867:Skin / Q000187:drug effects* / Q000378:metabolism
chemical_list: D003358:Cosmetics
keywords: 3D; Alternatives to animal testing; Cosmetics; Genotoxicity; Metabolism; Skin